CN107438414A - Heart valve prosthesis - Google Patents

Heart valve prosthesis Download PDF

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Publication number
CN107438414A
CN107438414A CN201680019560.9A CN201680019560A CN107438414A CN 107438414 A CN107438414 A CN 107438414A CN 201680019560 A CN201680019560 A CN 201680019560A CN 107438414 A CN107438414 A CN 107438414A
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CN
China
Prior art keywords
stabilizing ring
heart valve
valve prosthesis
specified
ring
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN201680019560.9A
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Chinese (zh)
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CN107438414B (en
Inventor
H-H·西弗斯
M·沙夫施韦特
A·霍夫
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Individual
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Individual
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Publication of CN107438414A publication Critical patent/CN107438414A/en
Application granted granted Critical
Publication of CN107438414B publication Critical patent/CN107438414B/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2409Support rings therefor, e.g. for connecting valves to tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0057Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof stretchable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/001Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a diameter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006Additional features; Implant or prostheses properties not otherwise provided for modular
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0071Additional features; Implant or prostheses properties not otherwise provided for breakable or frangible

Abstract

The present invention relates to a kind of heart valve prosthesis, and it has valve bracket (2), and multiple leaflets (8) are fixed with the valve bracket;And it is axially coupled to the fixed FX in the blood vessel that is used for of the valve bracket (2), wherein, stabilizing ring (14) is provided with the FX, the stabilizing ring limits the default shape of the FX and default diameter and has at least one specified stretching position (22), and the specified stretching position makes it possible to the power in the inner circumference by radial effect to the stabilizing ring to widen the stabilizing ring (14).

Description

Heart valve prosthesis
Technical field
The present invention relates to a kind of heart valve prosthesis, more particularly to a kind of artificial heart valve for being used to substitute aorta petal Film.
Background technology
A kind of for example, known heart valve prosthesis for being used to substitute aorta petal from DE 10 2,010 051 632. Following problems be present in this bio-artificial cardiac valves:The heart valve prosthesis can wear and must be replaced if necessary Generation.
The content of the invention
On described problem, the object of the present invention is to improve heart valve prosthesis, can pass through in a straightforward manner Another heart valve prosthesis substitutes.
The purpose of the present invention is realized by the heart valve prosthesis with the feature proposed in claim 1.It is preferred that Embodiment obtained in dependent claims, following specification and appended accompanying drawing.
Valve bracket is had according to the heart valve prosthesis of the present invention, multiple leaflets are fixed with the valve bracket. Here, it is preferably the leaflet made of biomaterial, this means, preferably bio-artificial cardiac valves.It is particularly preferred that set There are three leaflets, and the valve bracket is correspondingly formed with the holding element of three arcs, and these holding elements are at three Stretched in commissure (Kommissuren) and carry leaflet.Valve bracket is preferably made up of and to a certain extent metal Elastically deformable.
Axially, i.e., streamwise or formed with being adjacent to the valve bracket on the contrary with the flow direction useful In fixed FX in the blood vessel.Suture ring can be especially disposed in the FX, at the suture ring Can be by heart valve prosthesis and circular vascular suture.Stabilizing ring is provided with FX, the stabilizing ring, which limits, to be fixed The default shape in region and default diameter.Especially, the stabilizing ring preferably limits the maximum fluidity of heart valve prosthesis Cross section.The stabilizing ring is used for, and widens blood vessel if necessary, enabling actually realizes maximum fluidity cross section.
According to the present invention, stabilizing ring has at least one specified stretching position, and the specified stretching position makes it possible to pass through The masterpiece of radial direction on from internal action to its inner circumference is used for widening stabilizing ring.Specified stretching position is configured to, and it preferably exists Extend on the whole axial length of stabilizing ring so that the stabilizing ring can act in power to be extended in lower edge ring circumferential direction.
This characteristic of stabilizing ring can be used in, by heart valve prosthesis abrasion when by new heart valve prosthesis come Substitute, its mode is:New heart valve prosthesis is introduced to the inside of the heart valve prosthesis according to the present invention.This for example can be with Be through conduit cardiac-valve prosthesis, it is described to be introduced into blood vessel and existing artificial heart via conduit through conduit cardiac-valve prosthesis The inside of valve.In this place, then the new heart valve prosthesis is expanded, wherein, described power is applied to according to this hair In the inner circumference of the stabilizing ring of bright heart valve prosthesis so that stabilizing ring is in its specified stretching of stretching position and broadening.By This, heart valve prosthesis can be pressed off radially so that space internally is provided for new heart valve prosthesis, in It is the inside that new heart valve prosthesis can be made to be fixed on existing heart valve prosthesis, especially power cooperation and/or shape Ordinatedly fix.Here, the leaflet of old heart valve prosthesis is equally pressed outward on vascular wall.The broadening of retainer ring causes New heart valve prosthesis can be used, without being reduced significantly internal cross section.More precisely, so can be by new Heart valve prosthesis stabilizing ring and circular vascular tissue is all stretched so that it is transversal to obtain suitable flowing again Face.
It is preferred that specified stretching position is configured to, in order to widen stabilizing ring in the case where power acts on, it is necessary to more than predetermined border Power.It is preferred that so select the boundary force:It is no more than the boundary force in normal use and especially in implanted prosthetic heart valve, So as to damage stabilizing ring, i.e. stabilizing ring is inserted and fixed in blood vessel and in this place with manner discussed above non-stretchedly.It is excellent Boundary force selection is just to reach the boundary force by means of conduit when inserting new heart valve prosthesis by choosing.Here, then from Inside applies the big power more than boundary force, stretches specified stretching position, so that stabilizing ring extends along ring circumferential direction.
According to another preferred embodiment, stabilizing ring is made of metal, especially by Nitinol, titanium or other suitable Alloy is made.As an alternative, stabilizing ring can also be made up of suitable plastics.
Stabilizing ring preferably has this rigidity:It can resist radially from external action to power thereon without plasticity occurs Deformation, the power are applied on stabilizing ring by circular blood vessel when stabilizing ring stretches.It is preferred that stabilizing ring is resisted from the footpath of outside To pressure be more than from inside radial direction pressure.
According to a particularly preferred embodiment, at least one specified stretching position is configured to specified fracture location, On the specified fracture location, stabilizing ring is torn in a limiting fashion under power effect in its inner circumference.That is, in the specified stretching On position, stabilizing ring separates in a limiting fashion under enough power effects, so that it is widened.
Instead of specified fracture location, specified stretching position msy be also constructed to separated part, stable on the separated part The part opposite in ring circumferential direction of ring is against each other so that and stabilizing ring can be resisted from outside pressure, but Then widened under power effect from inside by the extension of separated part along ring circumferential direction.
According to another preferred embodiment, specified stretching position is configured to, in the ring Zhou Fang of power effect lower edge stabilizing ring To plastically stretching.Thus broadening of the stabilizing ring at specified stretching position is irreversible.That is, stabilizing ring is acted in power and cancelled The shape for keeping it to widen afterwards.Such specified stretching position is preferably configured as, and it not exclusively tears, so that stabilizing ring remains The ring of closing.
According to the present invention, at least one specified stretching position or specified fracture location are set in stabilizing ring.But according to one Individual particularly preferred embodiment, multiple specified stretching positions or specified fracture location can be set, these specified stretching positions Or specified fracture location was preferably evenly distributed on ring week.It is particularly preferred that three specified stretching positions, these volumes are set Surely stretching position is preferably arranged essentially on the commissural Angle Position of heart valve prosthesis.By this way, acted in power Under can realize uniform broadening, here, in commissural region, valve bracket is it is also preferred that can be deformed into, with stabilizing ring Broadening and widen.
In addition it is to be understood that specified stretching position, the volume that can realize plastic deformation can also be used in stabilizing ring The combination of fracture location and/or separated part is determined, to realize the desired characteristic of stabilizing ring, i.e., relative to the pressure from outside Resistivity and from inside power effect under tensility.
According to another preferred embodiment, stabilizing ring is arranged on the inside in encapsulating portion.Such encapsulating portion for example can be with It is made up of textile material, the textile material also encapsulates valve bracket.Such material can for example establish the company with suture ring Connect or be used as suture ring simultaneously, the line for suture is guided through the suture ring.
Encapsulating portion is preferably configured as, and it is correspondingly stretched when stabilizing ring is widened, i.e., with stabilizing ring stretch identical journey Degree stretching.Therefore encapsulating portion will not hinder the broadening of stabilizing ring.
As an alternative, encapsulating portion is configured to, and it is when stabilizing ring is widened, preferably at least one specified fracture location Tear.Thus also ensure that encapsulating portion will not hinder the broadening of stabilizing ring.In order to realize tear, the material in encapsulating portion is so selected Material:When integral material selection tears for the material under boundary force, the material is when beyond boundary force by along ring Zhou Fang Tear with being limited at least one specified fracture location to the tensile force of effect or torn at any position.Set one Or the advantages of multiple specified fracture locations is the tear that limits, it may thereby be ensured that not leaving the portion of the relaxation in encapsulating portion Point.
According to another preferred embodiment, stabilizing ring is connected with the decoupling of valve bracket power, and this causes valve bracket can To move relative to stabilizing ring and can especially be widened relative to stabilizing ring.Therefore, the curved portions of valve bracket can prolong Reach in sinus cavities sustainer, it is known such as from DE 102010051632.It can realize that maximum fluidity is transversal by this way Face.In addition, it is possible thereby to make valve bracket independently be widened with stabilizing ring when inserting new heart valve prosthesis, think new Heart valve prosthesis provides space.When inserting new heart valve prosthesis, stabilizing ring is due to described specified fracture location Or specified stretching position and broaden, and power decoupling valve bracket then preferably with the specified fracture location in stabilizing ring or specified drawing Extending portion position independently merely due to its elastically and/or plastically deformability and radially widen.
Particularly preferred valve bracket is elastically deformably formed.This aspect can support the opening and closing of leaflet to transport It is dynamic, on the other hand it can realize:Valve bracket can reduce on its diameter or cross section in order to insert and then widen, special It is not as described above, being inserted into sinus cavities sustainer.In addition can as described above, when stabilizing ring is widened, valve bracket Widened with another size, internally to provide space for new heart valve prosthesis.
Brief description of the drawings
The present invention exemplarily is described by accompanying drawing below.It is shown in the drawings:
Fig. 1 shows the stereogram of the heart valve prosthesis according to the present invention;
Fig. 2 shows the top view from bottom according to Fig. 1 heart valve prosthesis;
Fig. 3 shows the stereogram of the valve bracket and stabilizing ring according to Fig. 1 and Fig. 2 heart valve prosthesis;
Fig. 4 shows the side view of the valve bracket and stabilizing ring according to Fig. 3;
Fig. 5 shows the top view set seen from above of the valve bracket and stabilizing ring according to Fig. 4;
Fig. 6 shows the three-dimensional detail view of the stabilizing ring according to the present invention;
Fig. 7 shows the second embodiment of the stabilizing ring according to the present invention;
Fig. 8 shows the 3rd embodiment of the stabilizing ring according to the present invention;
Fig. 9 shows the 4th embodiment of the stabilizing ring according to the present invention.
Embodiment
The heart valve prosthesis according to the present invention shown in fig. 1 and 2 is such as shown inside it in Fig. 3 into Fig. 5 , there is valve bracket 2, the valve bracket has three curved portions 6, and these curved portions are on its end by connecting arc 7 It is connected with each other and then forms three commissures 4.Valve bracket 2 is shaped by wire, and the wire is elastically deformable.Three Individual curved portions 6 carry three leaflet 8 made of biomaterial.These envelope flaps or leaflet 8 contact on seamed edges 10 that at three This against and seal against each other in this place.In order to open, leaflet 8 is moved radially outward, and it is departed from contact seamed edge 10 and is connect Touch and expose central opening.
In addition, valve bracket 2 is encapsulated by encapsulating portion 12, the encapsulating portion is made up of textile material or textile material, described Valve bracket extends also above commissure 4 and comprehensively closes the commissure.Heart valve prosthesis positioned at downstream First axial end portion is limited by the connection arc 7 of commissure 4 or tip.Being formed on the opposite axial end portion positioned at upstream has admittedly Determine region.In this place, it is provided with stabilizing ring 14 in the inside in encapsulating portion 12.The stabilizing ring 14 is made of metal and with restriction Toroidal.Interior cross section that the interior cross section of stabilizing ring 14 is corresponded essentially between the tip of commissure 14 and Limit through the maximum fluidity cross section of heart valve prosthesis.This is especially visible in Figure 5.
With valve bracket 2 on the contrary, stabilizing ring 14 is rigidly formed, that is to say, that stabilizing ring has lower than valve bracket 2 Elasticity or elastic deformability.Especially, the substantially not elastically deformable in radial directions of stabilizing ring 14.The edge of stabilizing ring 14 Radial direction has penetrating part 16.These penetrating parts 16 allow to guide suture material or yarn to pass through stabilizing ring 14, will Heart valve prosthesis is fixed in the blood vessel on stabilizing ring 14.In addition, stabilizing ring 14 has three in its one axial end The commissure supporting part 18 stretched into the commissure 4 of valve bracket 2.These commissure supporting parts 18 are in the area of commissure 4 Encapsulating portion 12 is supported in domain, so that encapsulating portion 12 is maintained at the form of restriction.
Especially as visible in figure 6, stabilizing ring 14 also has axle on the Angle Position of commissure supporting part 18 in inner side To the recess 22 of extension.The recess 22 extends through heart valve prosthesis parallel to flow direction and forms specified fracture Position.When sufficiently large power is applied on stabilizing ring 14 from inner circumferential, stabilizing ring can tear or be broken in the region of recess 22, The specified fracture location fracture formed in this place, and stabilizing ring 14 can widen along ring circumferential direction, make stabilizing ring acquisition compared with Big diameter.Here, causing the deformation of commissure supporting part 18, for this, deformable ground is formed at the tip of commissure supporting part There are specified deformation or specified stretching position 23.These positions can also be alternatively to construct figure 9 illustrates in a manner of.Alternative Ground, specified fracture location can also be set in the region of commissure supporting part 18 at its tip.Meanwhile encapsulating portion 12 is formed For when the stabilizing ring is torn at its recess 22, the encapsulating portion can stretch with stabilizing ring 14.The design can Realize, another heart valve prosthesis is inserted in the inside of the heart valve prosthesis, then by the heart valve prosthesis radially Deploy and be pressed under force in the interior zone of stabilizing ring 14, so that stabilizing ring is broken and expanded at its recess 22 Open up and press to circular vascular tissue together with the FX of new heart valve prosthesis, blood vessel is equally extended.Cause This, new heart valve prosthesis can be fixed in the blood vessel, flow herein in the case of old heart valve prosthesis extension Cross section there is no diminution.This allows to insert new heart valve prosthesis by conduit, is so far without removing Heart valve prosthesis only.
It is to be understood that specified stretching position can also be formed instead of specified fracture location 22, according to the specified stretching Position, material are only plastically deformed under power effect, so that stabilizing ring 14 stretches along ring circumferential direction and thus extends its diameter.This Outside, recess 22 can also be only set.Instead of recess 22, it can also otherwise make material thinning or form with weakening, to carry For specified fracture or specified stretching position.
Fig. 7 shows the stabilizing ring 14 of alternative, and the stabilizing ring replaces the recess 22 as specified fracture location to have six Specified stretching position 24.These specified stretching positions 24 pass through bending of the material transverse to the ring circumferential direction of stabilizing ring 14 or spiral And formed, so as in the region at specified stretching position 24, the material of stabilizing ring can be plastically deformed so that stabilizing ring 14 can be with Stretched along ring circumferential direction.This is curved upwardly to realize by the spiral at specified stretching position 24.Commissure supporting part 18 With specified stretching position 23, as described by it by Fig. 6.
Also being formed in the stabilizing ring 14 according to Fig. 8 has specified stretching position 24, as described by it by Fig. 7. It is different from the embodiment according to Fig. 7, without the specified stretching position 23 of composition on the tip of commissure supporting part 18, but form Separated part 25.In separated part 25, the web for forming commissure supporting part 18 has continuous seam or continuous gap, this A little gaps are configured to, and the opposite side in these gaps can be contacting one another, to transmit pressure.But stretching can not be transmitted Power, the tensile force cause gap to be widened at separated part 25 so that when specified stretching position 24 stretches along ring circumferential direction, Commissure supporting part 18 can also be widened greatly by the change of separated part 25 along ring circumferential direction.
Fig. 9 shows another deformation program of stabilizing ring 14.The deformation program corresponds essentially to the deformation side according to Fig. 7 Case, wherein, the specified stretching position 23 ' in commissure supporting part 18 is herein also by the abdomen in formation commissure supporting part 18 Spire or curved portions in plate are formed.Specified stretching position 34 can also be drawn by the broadening of curved portions along ring circumferential direction Stretch.
Recess 22 and specified stretching position 23,23 ' and 24 are preferably configured as, and are just torn when more than predetermined boundary force Split.It is by boundary force selection, when heart valve prosthesis is inserted in blood vessel and in its routine during use, boundary force It will not be applied on stabilizing ring 14, so that stabilizing ring can be dimensionally stable in a manner of already described.Only already described by introducing Heart valve prosthesis inside conduit when inserting new heart valve prosthesis, sufficiently large power can be applied so that more than this Boundary force, and recess 22 is torn, or specified stretching position 23,23 ' and 24 stretches along ring circumferential direction.
It is to be understood that already described specified stretching position 23,23 ' and separated part 25 can also be together with specified fractures Position or the specified stretching position being differently composed are used together.In addition it is to be understood that instead of recess 22 or specified stretching position 24 can also set separated part in stabilizing ring 14, and these separated parts allow the broadening along ring circumferential direction, but make stabilizing ring Can be absorbed in 14 radially 14 from external action to stabilizing ring on pressure.In addition it is to be understood that other numbers can also be used The specified fracture location 22 or specified stretching position 23,23 ', 24 and separated part 25 of amount, so as on the one hand realize steady Determine enough stability of the ring relative to the pressure from outside, on the other hand realize the expansion under the power effect from inside It is wide.
As shown in Figure 3 and Figure 4, figure 1 illustrates the valve bracket 2 being arranged on inside heart valve prosthesis and stabilizing ring In 14 plan of establishment, valve bracket 2 and stabilizing ring 14 are not directly connected to each other.More precisely, valve bracket 2 and stabilizing ring 14 are only connected with each other by the flexible encapsulating portion 12 being made up of textile material or textile material, so as in valve bracket 2 and stably The connection of power decoupling is formed between ring 14.Due to the flexibility of the textile material in encapsulating portion 12, valve bracket 2 can be relative to stable Ring 14 moves.This causes valve bracket 2 to have an elastic deformability, elastic deformability especially radially, and steady Determining ring 14 will not then be deformed due to its rigid construction when inserting blood vessel.But pass through encapsulating portion 12, stabilizing ring 14 and valve Membrane support 2 forms prefabricated construction unit with the leaflet 8 formed in encapsulating portion 12, and the construction unit can be used as overall insert Enter in blood vessel, and operation when without installation operation or stabilizing ring 14 and with leaflet 8 valve bracket 2 between suture.
Fig. 3 to Fig. 5 shows the undeformed relaxed state of valve bracket 2.It is seen that the curved portions 6 of valve bracket 2 exist The outer shroud week of stabilizing ring 14 is extended radially beyond under the state, and commissure 4 was located substantially on the ring week of stabilizing ring 14.Cause This, the curved portions 6 of valve bracket 2 can be extended in sinus cavities sustainer under implanting state and then exposed transversal in maximum Face, the interior cross section correspond essentially to the natural cross section of sustainer.Therefore, shown heart valve prosthesis is in its size Aspect is mutually coordinated with corresponding blood vessel, the interior diameter of stabilizing ring 14 is corresponded essentially to natural interior diameter or the summary of sustainer More than the natural interior diameter of sustainer.Thus, in insertion vascular tissue can be made to widen to a certain extent, so as in totality On flow cross section will not be made to be limited by heart valve prosthesis.Therefore, it is preferred that stabilizing ring 14 is configured to, it can absorb Radial pressure from outside, without causing fracturing and shearing off for the specified fracture location formed by recess 22.Therefore, these Specified fracture location is configured to, and they can absorb more tensile forces than pressure.
In order to insert, valve bracket 2 can, it is known such as from the B4 of DE 10 2,001 051 622, radially-inwardly transport Dynamic, so that curved portions 6 are deformed radially inwardly, and largest outer diameter is limited by stabilizing ring 14.It thereby simplify suture.Stitching After conjunction, this deformation of valve bracket 2 can be discharged, enables curved portions 6 and then as described hereinbefore due to it Elasticity and extended and can especially be expanded in sinus cavities sustainer again.This is particularly due to valve bracket 2 stable Flexible, power decoupling connection on ring 14 but it is feasible.Stabilizing ring 14 is formed sufficiently rigidly, to limit heart valve prosthesis Interior cross section and be securely inserted into blood vessel, fix in sustainer and in this place.Here, stabilizing ring 14 is previously given The specific size and shape of heart valve prosthesis and especially its flow cross section.
Stabilizing ring 14 can be made up of marmem, such as Nitinol, so that stabilizing ring before insertion can be radially Deformation, reduce its external cross section.After the insertion, due to temperature change stabilizing ring can to return change to it is shown just Beginning shape, and be then securely fixed in blood vessel, stabilizing ring is as the desired cross section of rigid structure qualification in this place.
The suture ring 20 being made up of textile material or textile material is additionally provided with outer shroud week in encapsulating portion 12, it is described Suture ring overlaps in outer shroud Zhou Shangyu stabilizing rings 14.This allows to so sew up heart valve prosthesis in blood vessel:Make blood vessel Tissue is placed between stabilizing ring 14 and suture ring 20, and the line for suture can be directed across to suture ring 20, positioned at it Between tissue, then pass through stabilizing ring 14.Here, suture material is guided through the encapsulating portion that surrounds stabilizing ring 14 and steady Determine the penetrating part 16 in ring 14.Thus, bearing when stabilizing ring 14 is formed in suture, without additional felt (Filze) it is used as bearing.
Reference numerals list
2 valve brackets
4 commissures
6 curved portions
7 connection arcs
8 leaflets
10 contact seamed edges
12 encapsulating portions
14 stabilizing rings
16 penetrating parts
18 commissure supporting parts
20 suture rings
22 recesses/specified fracture location
23rd, 23 ', 24 specified stretching position
25 separated parts.

Claims (10)

1. a kind of heart valve prosthesis, there is valve bracket (2), multiple leaflets (8) are fixed with the valve bracket;And The fixed FX in the blood vessel that is used for being axially coupled on the valve bracket (2), wherein, in the FX Provided with stabilizing ring (14), the stabilizing ring limits the default shape and default diameter and with least of the FX One specified stretching position (23,23 ', 24), the specified stretching position makes it possible to by radial effect to the stabilizing ring Inner circumference on power widen the stabilizing ring (14).
2. heart valve prosthesis according to claim 1, wherein, the specified stretching position (23,23 ', 24) is configured to, In order to widen the stabilizing ring (14) in the case where power acts on, it is necessary to more than predetermined boundary force.
3. heart valve prosthesis according to claim 1 or 2, wherein, the stabilizing ring (14) is made of metal.
4. the heart valve prosthesis according to one of the claims, wherein, at least one specified stretching position (23,23 ', 24) are configured to specified fracture location (22), and on the specified fracture location, the stabilizing ring (14) acts in power Under in its inner circumference limit tear.
5. the heart valve prosthesis according to one of claims 1 to 3, wherein, the specified stretching position (23,23 ', 24) It is configured to, is plastically stretched in the ring circumferential direction of stabilizing ring (14) described in power effect lower edge.
6. the heart valve prosthesis according to one of the claims, wherein, the stabilizing ring (14) is arranged on encapsulating portion (12) inside.
7. heart valve prosthesis according to claim 6, wherein, the encapsulating portion (12) is stretchable, the encapsulating Portion correspondingly stretches when the stabilizing ring (14) is widened.
8. heart valve prosthesis according to claim 6, wherein, the encapsulating portion (12) is configured to, and the encapsulating portion exists During stabilizing ring (14) broadening, torn preferably at least one specified fracture location.
9. the heart valve prosthesis according to one of the claims, wherein, the stabilizing ring (14) and the valve branch Frame (2) power decoupling ground connection.
10. the heart valve prosthesis according to one of the claims, wherein, the valve bracket (2) is configured to can bullet Property deformation.
CN201680019560.9A 2015-04-02 2016-03-23 Heart valve prosthesis Active CN107438414B (en)

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DE102015206099.3A DE102015206099A1 (en) 2015-04-02 2015-04-02 Heart valve prosthesis
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PCT/DE2016/200151 WO2016155730A1 (en) 2015-04-02 2016-03-23 Prosthetic heart valve

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US20180078366A1 (en) 2018-03-22
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DE102015206099A1 (en) 2016-10-06
WO2016155730A1 (en) 2016-10-06

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